Overview
The Associate Director, Global Development Quality Inspection Management (GDQIM) acting as an Inspection Management Lead (IML) is responsible for the effective management of GCP, GVP and GLP inspections. The GDQIM IML engages with key stakeholders, builds strategic partnerships, and supports Clinical Study teams and other GDQ functions with inspection preparation activities for all Regeneron-sponsored clinical trials.
Responsibilities
* Ensure and manage the notification of all relevant internal and external stakeholders of upcoming and/or anticipated regulatory inspections.
* Prepare, manage and integrate inspection management processes and training activities into the clinical development programs and all relevant stakeholders.
* Provide effective guidance, consultancy, and support to the Clinical Study Teams and other key stakeholders in advance of an impending inspection.
* Assist in the identification of opportunities to conduct mock inspections and/or Investigator Site Preparation Visits in collaboration with the GD Quality Assurance (GDQA) team and other relevant functional groups.
* Identify and discuss potential issues and/or gaps with the Clinical Study Teams in advance of an impending inspection that may require strategies to mitigate risk or provide additional clarification to an inspector.
* Ensure the preparation, management and conduct of inspection preparation sessions, including mock inspections, trainings, and clinical site preparation visits, working with GDQA team to identify and mitigate risks to clinical programs.
* Serve as the back room lead/co‑lead or front room co‑lead, responsible for explaining, managing, and ensuring the execution of all activities, managing the tracking of requests and inquiries, and coordinating requests for responses from relevant personnel during any regulatory inspection worldwide.
* Manage the preparation and provision of timely inspection updates and daily/end‑of‑inspection summaries to GD Executive and Senior Management, and other key stakeholders.
* Manage inspection response development, and Corrective Actions/Preventive Actions (CAPA) follow‑up activities alongside other GDQIM colleagues, cross‑functional stakeholders, and process owners.
* Ensure and manage the development, collection, reporting and analysis of inspection‑related quality data, trends, and metrics.
Qualifications – This role may be for you if
* Advanced knowledge, understanding and application of GCP, and/or GVP guidelines, including the management of significant/complex quality issues and compliance activities.
* Extensive experience with participating in and supporting regulatory agency inspections of investigator sites, sponsors, and clinical research organizations (CROs) in a GxP environment, including inspection preparation, facilitation, and follow‑up.
* Effective management of interpersonal relationships, stakeholder engagement, and collaborations.
* Demonstrated ability to interface and collaborate effectively with other Managers and Directors within, and external to, the organization.
* Extensive experience in providing training and presenting information on key quality and regulatory compliance information.
To be considered for this opportunity we are looking for
* Bachelor's degree with a minimum of 10 years of relevant healthcare/pharmaceutical industry experience.
* Experience working in either a quality/compliance role (e.g., Quality Management, Quality Assurance, etc.) or in a Clinical Development role with expertise and/or transferable skills related to Good Clinical Practice (GCP) and/or Good Pharmacovigilance Practice (GVP).
* Experience in training, supervising, line management, mentoring and development of staff, and leading a small team.
Benefits
We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels!
EEO Statement
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
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